The marketing authorisation holder is required to keep scientifically up-to-date the package leaflet which includes the conclusions of assessments and recommendations published on the European internet website set up pursuant to Article 26 of Regulation EC No.

The company to be indicated under sub-section 1 number 1 may be abbreviated, provided that the firm is generally recognizable from the abbreviation. Zusammenfassung Ihres Vorhabens Halten Sie sich hier kurz und knapp.

Section 9 The party responsible for placing on the market 1 Medicinal products that are placed on the market within the purview of the present Act shall bear the name or the company and the address of the pharmaceutical entrepreneur.

The information pursuant to sentence 1 numbers 13 and 14 only need to be given on the outer packaging where an outer packaging exists.

Should additional information be given on the package leaflet, it shall be clearly set out and well separated from the information specified in sub-sections 1 to 4. In so far as the information pursuant to sentence 1 is also provided in another language, the information provided in that language shall be identical.

Additional information is permitted in so far as it relates to the use of the medicinal product, is important for the user or animal keeper and is not inconsistent with the information referred to in Section 11a. Sub-section 5 shall apply mutatis mutandis. Erstellen Sie hier am besten noch mal ein Extra-Konzept.

Additional information which is not stipulated by a regulation of the European Community or the European Union, or is already admissible pursuant to such a regulation, shall be permitted if it is linked to the use of the medicinal product, is important in providing health information to the patient and is not inconsistent with the information referred to in Section 11a.

is and in to a was not you i of it the be he his but for are this that by on at they with which she or from had we will have an what been one if would who has her. Ein Unternehmer kann sich beim Erstellen seines Businessplans auf ein vorgefertigtes Muster stützen.